BTG plc: Interim Results

 

17% product sales growth, reiterating full year guidance

 

Continued delivery of Interventional Medicine growth strategy

 

London, UK, 14 November 2017: BTG plc (LSE: BTG), a global specialist healthcare company, today announces its interim results for the half year ended 30 September 2017.

 

"We have delivered strong product sales growth in H1 and have also made significant progress with activities that support sustainable high growth in our Interventional Medicine business," commented Louise Makin, BTG's CEO. "We have built a scalable platform, with a portfolio of differentiated products, strong customer relationships and internal capabilities, with multiple drivers of growth in our existing business. The use of minimally invasive therapies continues to grow. We have the financial resources and capabilities to continue to make targeted new investments, so that we can expand our Interventional Medicine business and deliver sustained growth in shareholder value."

Financial highlights

		H1 2017/18 (£m)	H1 2016/17 (£m)	Growth (%)	Growth at CER2 (%)
Revenue Product sales		341.3 239.7	285.4 193.2	20% 24%	13% 17%
Adjusted operating profit1		99.1	78.8	26%	15%
IFRS operating profit		18.6	29.1	(36%)
Adjusted basic EPS1		21.0p	13.9p	51%
IFRS basic EPS		13.8p	3.4p	>100%
Free cash flow1 Net cash flow from operating activities		75.2 78.8	55.7 60.8	35% 30%

1.     Certain financial measures in this press release, including adjusted operating profit, adjusted basic EPS and free cash flow are not prepared in accordance with IFRS. All adjusted financial measures are explained on page 23 and are reconciled to the most directly comparable measure prepared in accordance with IFRS on pages 24 to 26.

2.     Constant Exchange Rate ("CER") growth is computed by restating H1 2017/18 results using H1 2016/17 foreign exchange rates for the relevant period.

 

·    Product sales 17% higher at CER, driven by Interventional Oncology, Interventional Vascular and Pharmaceuticals; reiterating full year guidance

·    Strong growth in adjusted operating profit, up 15% at CER; IFRS operating profit declined by 36% and was impacted by provision of £53.5m following final court ruling in previously announced Wellstat litigation

·    Adjusted basic EPS up 51%, benefitting from gains on foreign exchange forward contracts compared with losses in H1 2016/17; IFRS basic EPS benefits from credit of £26.5m from release of contingent consideration liability for PneumRx^® Coil regulatory milestone

·    Continued strong cash generation, with free cash flow up 35%

 

Operational highlights

 

Interventional Medicine

 

Oncology

·       Patient enrolment completed in TheraSphere® STOP-HCC trial; data expected in 2019

·       MOTION and SOLSTICE studies exploring cryoablation for treating bone and lung metastases fully enrolled and on track to report data in 2018

·       Expanded collaboration with the Society of Interventional Oncology, exploring the combination of locoregional therapies and immuno-oncology agents

 

Vascular

·    Positive data reported in EKOS^® OPTALYSE PE and ACCESS PTS studies

·    Acquisition of Roxwood Medical, a provider of advanced specialty cardiovascular catheters, leveraging Interventional Vascular US national hospital sales force

 

Early-stage products

·    PneumRx^® Coil US regulatory review ongoing, approval anticipated in H2 2018 calendar year

·    Category I CPT codes finalised for Varithena^® procedures in the US, effective from January 2018

 

Pharmaceuticals

·    Education and awareness activities continue to support optimum use and stocking of CroFab^® and DigiFab^®, and continued growth of Voraxaze^®

·    Vistogard^® distribution agreement terminated; BTG to return all rights to Wellstat Therapeutics Corporation

 

Licensing

·    Back-royalties of £11.0m received on Lemtrada^™; good performance from Zytiga^®

 

For further information contact:

 

BTG	FTI Consulting
Andy Burrows, VP Corporate & Investor Relations	Ben Atwell / Simon Conway
+44 (0)20 7575 1741; Mobile: +44 (0)7990 530 605	+44 (0)20 3727 1000
Stuart Hunt, Investor Relations Manager
+44 (0)20 7575 1582; Mobile: +44 (0)7815 778 536
Chris Sampson, Corporate Communications Director
+44 (0)20 7575 1595; Mobile: +44 (0)7773 251 178

 

 

About BTG

 

BTG is a global specialist healthcare company bringing to market innovative products in specialist areas of medicine to better serve doctors and their patients. We have a portfolio of Interventional Medicine products to advance the treatment of cancer, severe emphysema, severe blood clots and varicose veins, and Pharmaceuticals that help patients overexposed to certain medications or toxins. Inspired by patient and physician needs, BTG is investing to expand its portfolio to address some of today's most complex healthcare challenges. To learn more about BTG, please visit: btgplc.com.

 

 

OPERATING REVIEW

 

The Group has delivered a very good financial performance in the six months to 30 September 2017, reflecting strong growth in product sales and higher than expected royalties. The Group has also made significant progress in delivering on its Interventional Medicine growth strategy.

 

Strategy

 

The Group's strategy is to establish leadership positions in selected therapy areas where there are large patient populations with unmet needs. BTG provides differentiated products and invests both organically and through acquisitions in innovative technology, clinical data and geographic expansion to deliver sustained growth and to enable its specialist physician customers to treat more patients.

 

There has been significant operational progress across BTG's business in the first half of the year.

 

Interventional Medicine - high growth

 

Interventional Oncology

 

With several treatment modalities, continued strong positions in growing markets and excellent customer relationships, BTG is a leader in Interventional Oncology. Significant progress has been made with the multiple activities that support the sustained high growth of this business.

 

The TheraSphere^® Phase III trials are progressing well, with data expected in 2019. Enrolment of 526 patients with unresectable hepatocellular carcinoma (HCC) was completed in the STOP-HCC trial, and approximately two-thirds of patients with metastatic colorectal cancer (mCRC) who have failed first-line chemotherapy have now been enrolled in the EPOCH trial. Both trials are intended to support Premarket Approvals (PMAs) of TheraSphere^® in the US.

 

Personalised treatment of patients is a key theme in medicine. BTG has partnered with Mirada, the medical imaging software company, to develop advanced dosimetry software that enables physicians to personalise TheraSphere^® Y⁹⁰ treatment for every patient.

 

Since acquiring Galil Medical in June 2016, integration of the business has proceeded as planned. The MOTION and SOLSTICE studies, using cryoablation for the palliation of bone metastases and for treating pulmonary metastatic disease, are both fully enrolled and on track to report data in 2018. BTG has invested in the Galil team and created a centre of excellence in BTG for ablation. A range of development programmes have been initiated, which have the potential to deliver several new products over the next 12-24 months.

 

BTG expanded its collaboration with the Society of Interventional Oncology to evaluate the combination of BTG's locoregional therapies with immuno-oncology agents. The aim is to improve scientific understanding of how locoregional treatment may enhance the effects of immuno-oncology agents by de-bulking tumours and releasing antigens that can stimulate a tumour-specific immune response. BTG will award eight research grants in total.

 

Geographic expansion has continued, with regulatory approvals and commencement of commercial activities in a number of territories in Asia, EMEA and Latin America.

 

Interventional Vascular

 

The Interventional Vascular business now has a full US national sales force of 60 people, and US hospital penetration has increased to ~80%. Expansion in other territories continues. In the EU, the sales and medical presence in major markets has been strengthened to support revenue growth and expand reimbursement, including in Germany where a new small direct sales force is being established.

 

The acquisition of Roxwood Medical in October 2017 leverages the US EKOS^® hospital sales force with a product that enables physicians to conduct more procedures and help more patients, while increasing BTG's per-visit revenue. Roxwood produces anchoring catheters that help physicians to cross complex lesions and arterial blockages, enabling further treatments. BTG will transition Roxwood's products to direct sales during H2.

 

Use of the EKOS^® catheter to treat pulmonary embolism (PE) continues to increase, with future growth supported by recent data from the OPTALYSE PE study. This showed that PE can be treated effectively with EKOS^® using lower doses of thrombolytic drug and shorter treatment times than the standard protocol, which allows for scheduling flexibility and efficiencies in clinician time and drug costs. EKOS^® is the only device cleared by the US Food and Drug Administration (FDA) for use in treating PE.

 

Positive data were also reported from the ACCESS PTS study, which found that patients with chronic deep vein thrombosis (DVT) and post-thrombotic syndrome (PTS) can be treated safely and effectively with a combination of EKOS^® therapy and balloon dilatation. As the only treatment regimen proven to significantly reduce the signs and symptoms of PTS and show a significant improvement in quality of life, over time this could provide another new procedure for treating physicians.

 

Interventional Medicine - early stage

 

BTG's early-stage Interventional Medicine products are the PneumRx^® Coil, a treatment for severe emphysema, and Varithena^®, a treatment for varicose veins. Varithena^® is considered as separate to BTG's Interventional Vascular business because it is sold through a separate sales force to physicians in private clinics.

 

PneumRx^® Coil

 

The PneumRx^® Coil system has been shown in clinical studies to improve lung function, exercise capacity and quality of life in patients with severe emphysema. It is one of the first devices available in the emerging medical field of Interventional Pulmonology, and BTG is progressing a range of activities that support the development of an Interventional Pulmonology business.

 

The product has received a CE Mark in the EU and currently most sales are in Germany. Activities to expand therapy adoption are ongoing. These include providing physicians with practical tools to select patients who are likely to respond well to treatment with the coils, and education and market development activities to ensure patient referrals from pulmonologists to interventional pulmonologists. BTG also plans to generate additional clinical data in a new study of patients with similar profiles to those who have responded well to coil treatment in previous studies.

 

Work continues in the EU to extend reimbursement. The German government review of reimbursement of treatments for severe emphysema is expected to conclude in H2 2018. In France, the Coil has been excluded from the add-on payment list but BTG intends to appeal this decision and in parallel continues to explore alternative reimbursement pathways.

 

In the US, where no devices are currently approved for treating severe emphysema, a PMA has been submitted and is being reviewed by the FDA. Current expectations are for potential approval and launch in H2 of the 2018 calendar year.

 

Varithena^®

 

Varithena^® is BTG's comprehensive treatment for varicose veins, which is approved in the US and is being sold by a dedicated small sales force to private vein clinics. A broad range of insurers have added Varithena^® to their coverage policies since launch, but the product has been reimbursed through interim codes and adoption has been hampered by slow processing of claims and variability in amounts paid to treating physicians.

 

Finalised category I CPT reimbursement codes have now been assigned to Varithena^® and will be effective from January 2018. The new CPT codes define Medicare payment rates and enable automatic and electronic processing of claims, providing physicians in the US with further predictability of payment and streamlining the reimbursement process. BTG believes that the new codes are appropriate and have the potential to underpin the Company's expectations for the product. However, it is likely to take until the end of 2018 for the impact of the new codes on physician adoption and insurer practices to be better understood.

 

Pharmaceuticals

 

BTG has renamed this business, as the former name, Specialty Pharmaceuticals, has come to be associated with a different business model to BTG's and a price-based approach to growth.

 

Physician education and awareness initiatives continue to drive optimum use of BTG's antidotes. Severe weather in the US led to strong demand for CroFab^® in anticipation of increased snakebites, and orders for the digoxin overdose antidote DigiFab^® benefitted in H1 from replacement of a number of expired batches in US hospitals. Growth of the high-dose methotrexate antidote Voraxaze^® continues, as awareness of methotrexate toxicity and treatment options increases.

 

The distribution agreement with Wellstat Therapeutics Corporation relating to Vistogard^® has been terminated following receipt of the final court ruling in the previously disclosed litigation with Wellstat. BTG will return all rights to Vistogard^® to Wellstat as soon as practicable, while continuing to consider appeal options.

 

Licensing

 

Licensing is no longer an active strategy for BTG, but the Group expects to continue to receive royalties from certain of its previously licensed technologies for some years to come.

 

During the period BTG received its final revenue relating to Lemtrada^™, Sanofi/Genzyme's treatment for multiple sclerosis. There was good growth in royalties received from sales of Johnson & Johnson's prostate cancer treatment, Zytiga^®, following positive data from two clinical studies that showed benefits in men who were initiated on Zytiga^® treatment alongside hormone therapy rather than after hormone therapy stops being effective.

 

 

FINANCIAL REVIEW

 

This review includes financial metrics on both an IFRS and adjusted basis. Information on the Group's adjusted financial information is set out on pages 23 to 26.

 

Revenue

 

Product Sales were £239.7m (H1 2016/17: £193.2m), up 17% at CER, with growth driven by Interventional Oncology, Interventional Vascular and Pharmaceuticals. Interventional Medicine grew 15% at CER, and Pharmaceuticals delivered a strong performance in the period, up 20% at CER. At actual exchange rates product sales were up 24%.

 

Revenues were £341.3m (H1 2016/17: £285.4m), up 13% at CER and up 20% at actual exchange rates. Revenues in the period benefited by £11.0m of Lemtrada^™ back-royalties and a good contribution from Zytiga^® royalties.

 

	H1 2017/18 £m	H1 2016/17 £m	Growth %	Growth at CER %
Interventional Oncology	76.6	63.2	21	15
Interventional Vascular	35.4	28.4	25	18
Early-stage Interventional Medicine
PneumRx®	4.0	4.8	(17)	(23)
Varithena®	2.8	1.7	65	57
Total Interventional Medicine	118.8	98.1	21	15
CroFab®	79.6	62.1	28	21
DigiFab®	27.0	21.8	24	18
Voraxaze®	12.2	9.5	28	23
Vistogard® /other	2.1	1.7	24	14
Total Pharmaceuticals	120.9	95.1	27	20
Total Product Sales	239.7	193.2	24	17
Zytiga®	71.0	65.8	8	3
Lemtrada™	21.6	17.0	27	17
Other	9.0	9.4	(4)	(10)
Total Licensing	101.6	92.2	10	4
Total Revenues	341.3	285.4	20	13

 

Interventional Medicine

 

Interventional Medicine revenues increased to £118.8m (H1 2016/17: £98.1m), up 15% at CER.

 

Interventional Oncology revenues were up 15% at CER to £76.6m (H1 2016/17: £63.2m) driven by the continued expansion of TheraSphere^® and continued growth in the number of cryoablation procedures.

 

Interventional Vascular revenues were £35.4m (H1 2016/17: £28.4m), up 18% at CER. Growth from the EKOS^® blood clot treatment device was driven by increased penetration into US hospitals and continued growth in treating PE.

 

Revenues of the PneumRx^® Coil treatment for severe emphysema were £4.0m (H1 2016/17: £4.8m), down 23% at CER due to a lower number of procedures in Germany, the largest market. Resumption of growth is anticipated when appropriate patient selection criteria are established and as reimbursement coverage expands.

 

Sales of the varicose veins treatment Varithena^® were £2.8m (H1 2016/17: £1.7m), reflecting continued steady progress from targeted marketing and market access initiatives ahead of new reimbursement codes in the US from January 2018.

 

Pharmaceuticals

 

Pharmaceuticals revenues were £120.9m (H1 2016/17: £95.1m), up 20% at CER.

 

Sales of CroFab^®, the snakebite antivenin, were up 21% at CER driven by volume growth and the benefit of single digit price increases. The digoxin toxicity treatment DigiFab^® delivered strong first half growth, up 18% at CER. This growth is not expected to be repeated in the second half with lower batch expiry sales expected compared to the high number of batch expiries in H2 2016/17.

 

Sales of Voraxaze^®, used for treating high-dose methotrexate toxicity, were 23% higher at CER, and sales from Vistogard^® were £2.1m (H1 2016/17: £1.7m); BTG expects to report its final revenue from Vistogard^® in H2 as all rights will be transferred back to Wellstat as soon as practicable.

 

Licensing

 

Licensing revenues were £101.6m (H1 2016/17: £92.2m), up 4% at CER.

 

Royalties from Zytiga^® (abiraterone acetate) were £71.0m (H1 2016/17: £65.8m), up 3% at CER, aided by a very strong performance from Zytiga^® in the last reported quarter.

 

Royalties from Lemtrada^™ increased to £21.6m (H1 2016/17: £17.0m) and include £11.0m of back-royalties received during the period. Lemtrada^™ royalties have now ceased.

 

Gross profit

 

Adjusted gross profit was £237.2m (H1 2016/17: £197.4m), with an adjusted gross margin of 69%
(H1 2016/17: 69%).

 

Interventional Medicine adjusted gross margin remained constant at 71% (H1 2016/17: 71%), reflecting the fixed manufacturing cost base for the early-stage Varithena^® and PneumRx^® Coil products, with improvement expected over time as revenues from these products grow. Pharmaceuticals gross margin was 88% (H1 2016/17: 89%), and Licensing gross margin remained constant at 46% (H1 2016/17: 46%).

 

On an IFRS basis, gross profit was £237.1m (H1 2016/17: £196.7m), representing a gross margin of 69%
(H1 2016/17: 69%).

 

SG&A

 

Adjusted SG&A was up 8% at CER, with the increase reflecting targeted commercial investment in Interventional Medicine, coupled with continued effective cost management. Adjusted SG&A was £93.2m (H1 2016/17: £82.4m), up 13% at actual exchange rates.

 

On an IFRS basis SG&A was £152.2m (H1 2016/17: £110.4m) and includes a charge of £53.5m in relation to the previously disclosed litigation with Wellstat and intangible asset impairment charges of £5.5m relating to the Vistogard^® intangible asset. SG&A in H1 2016/17 included a charge of £28.0m relating to the settlement with the US government in relation to the Department of Justice investigation into the historical marketing of LC Bead^®.

 

Research and development

 

R&D expenditure increased by 16% at CER, reflecting increased investment primarily in Interventional Oncology programmes, including the STOP-HCC and EPOCH TheraSphere^® trials as well as support for a number of ablation projects. Research and development was up 22% to £46.1m (H1 2016/17: £37.8m) at actual exchange rates.

 

Operating profit

 

On a CER basis, adjusted operating profit was up 15% reflecting higher revenues and targeted investment in Interventional Medicine, coupled with continued effective cost management. Adjusted operating profit was £99.1m (H1 2016/17: £78.8m), up 26% at actual exchange rates.

 

Adjusted operating margin increased to 29% (H1 2016/17: 28%). IFRS operating margin was 5% (H1 2016/17:  10%).

 

On an IFRS basis, operating profit was £18.6m (H1 2016/17: £29.1m), down 36% at actual exchange rates, and includes a provision of £53.5m in respect of the litigation with Wellstat. In H1 2016/17 IFRS operating profit included a charge of £28.0m in respect of the settlement with the US government relating to the historic marketing of LC Bead^®.

 

Financial expense/income

 

Adjusted net financial income was £5.8m (H1 2016/17: net financial expense of £17.7m).

 

Financial income in H1 2017/18 principally related to gains of £6.6m on foreign exchange forward contracts, following the strengthening of sterling in the period. Financial expense in H1 2016/17 related to foreign exchange forward contract losses of £17.0m following the weakening of sterling in the first half of last year.

 

IFRS net financial income was £28.6m (H1 2016/17: net financial expense of £18.0m). In addition to foreign exchange forward contract gains, IFRS net financial income in H1 2017/18 includes a net credit of £22.8m relating to the change in fair value of contingent consideration liabilities (H1 2016/17: net expense of £0.3m), principally due to a fair value credit of £26.5m relating to the PneumRx^® Coil regulatory approval milestone.

 

The Group now considers that FDA approval of the PneumRx^® Coil will not be received before 31 December 2017. As a consequence, a credit of £26.5m has been recognised relating to the contingent consideration liability for the $60m milestone payment that would be payable if FDA approval occurs before 31 December 2017.

 

Taxation

 

Adjusted effective tax rate was 23% (H1 2016/17: 13%). The adjusted effective rate is above the standard rate of UK corporate tax due to a significant portion of the Group's profit arising in the US. The effect of the high US corporate tax rate is partly offset by the patent box deduction on royalty income, the benefit of US R&D tax credits and the recognition of deferred tax assets for historical losses and timing differences.

 

On an IFRS basis, there is a tax credit of £5.7m (H1 2016/17: £1.8m). The tax credit arises from expected tax relief for litigation provisions and deferred tax credits relating to amortisation on acquired intangible assets.

 

Earnings per share

 

Adjusted basic EPS was 21.0p (H1 2016/17: 13.9p), up 51% due to higher adjusted profit after tax, before non-controlling interests, of £81.2m (H1 2016/17: £53.4m). Adjusted profit after tax was higher in H1 2017/18 due to growth in adjusted operating profit and foreign exchange forward contract gains in H1 2017/18 compared to losses in H1 2016/17.

 

IFRS basic EPS was 13.8p (H1 2016/17: 3.4p), due to higher IFRS profit after tax and before non-controlling interests of £53.3m (H1 2016/17: £12.9m). Lower IFRS operating profit was more than offset by the favourable impact of gains of £6.6m on foreign exchange forward contracts in H1 2017/18 compared to losses of £17.0m in H1 2016/17, and a net credit of £22.8m from changes in the fair value of contingent consideration liabilities.

 

Balance sheet

 

Non-current assets

 

Non-current assets decreased to £892.7m (31 March 2017: £968.8m). Intangible assets decreased to £613.9m (31 March 2017: £678.9m) due to amortisation, the impairment of Vistogard^® and the impact of foreign exchange. Goodwill decreased to £216.0m (31 March 2017: £225.6m) due to the impact of foreign exchange.

 

Current assets

Current assets increased to £412.0m (31 March 2017: £342.3m). Cash and cash equivalents were higher at £226.5m (31 March 2017: £155.5m) reflecting continued strong cash generation.

 

Non-current liabilities

 

Non-current liabilities decreased to £137.6m (31 March 2017: £165.7m) principally due to foreign exchange retranslation of deferred tax liabilities.

 

Current liabilities

 

Current liabilities increased to £177.9m (31 March 2017: £165.5m). Trade and other payables decreased to £117.5m (31 March 2017: £152.0m) principally due to a reduction in the fair values of contingent consideration liabilities in relation to the PneumRx acquisition. Derivative financial instrument liabilities decreased to £1.1m (31 March 2017: £7.9m) due to changes in the fair values of foreign exchange forward contracts in the period.

 

These decreases were more than offset by an increase in provisions, principally due to the recognition of a litigation provision of £53.5m to cover the damages and estimated interest plus costs at 30 September 2017 following the final court ruling in respect of the previously announced litigation with Wellstat. BTG is currently assessing appeal options.

 

Cash flow

 

The business continues to be highly cash generative. Free cash flow was £75.2m (H1 2016/17: £55.7m), up 35%, as the business converted strong growth in adjusted operating profit into cash.

 

On an IFRS basis, cash flow from operating activities was up 30% to £78.8m (H1 2016/17: £60.8m).

 

Cash and cash equivalents were £226.5m at 30 September 2017 (31 March 2017: £155.5m). In October 2017, the Group acquired Roxwood Medical for a cash payment of US$65m (subject to customary closing adjustments).

 

On 7 November 2017, the Group re-financed its multi-currency revolving credit facility ("RCF") which was otherwise due to expire in November 2018. Following the re-financing, BTG has a £150m multi-currency RCF, with an option to increase the RCF by a further £150m. The RCF has a three-year term which expires in November 2020, although the Group has the option to extend the term of the RCF for up to an additional two years. The RCF currently remains undrawn.

 

 

SUMMARY AND OUTLOOK

 

BTG has delivered a very good financial performance in H1, with strong growth in Interventional Medicine and Pharmaceuticals sales and higher Licensing revenues than expected. Further growth is expected in H2 in Interventional Medicine product sales driven by continued growth in the Interventional Oncology and Interventional Vascular portfolios. Pharmaceuticals revenues in H2 will reflect the H1-weighted seasonality of CroFab^® and fewer anticipated expiry orders for DigiFab^® compared with H2 2016/17.

 

BTG has built a scalable platform, with a broad portfolio of differentiated products, strong commercial teams and customer relationships, and innovation and development capabilities. Past investments mean there are multiple drivers of growth in BTG's existing business. As the use of minimally invasive therapies increases, BTG has the financial resources and capabilities to continue to make targeted new investments to expand its Interventional Medicine business and deliver sustained growth in shareholder value.

 

The Group's overall outlook for the full year to 31 March 2018 remains unchanged:

 

	2017/18 CER guidance1	Comment
Interventional Medicine	mid-to-high teens (%) growth	H2 weighted
Pharmaceuticals	low-to-mid single digit (%) growth	H1 weighted
Royalties	single digit (%) decline	Increased Zytiga® royalties and Lemtrada™ back-royalties
Gross margin	within range 69% - 71%	Higher Licensing revenues / mix
Adjusted SG&A2 and R&D	mid-to-high single digit (%) increase	No change
Adjusted effective tax rate2	increasing to 22% - 26%	No change

 

¹ The average USD/GBP rate for the year ended 31 March 2017 was $1.31

² Adjusted SG&A and Adjusted effective tax rate is not prepared in accordance with IFRS. Further detail on the Group's adjusted financial measures is included on pages 23 to 26.

 

Currency sensitivity

 

A further 5 cent change in USD/GBP rates (from the 30 September 2017 rate of ~$1.34) would result in an incremental hedging gain/loss of £3m on current forward contracts in the second half of 2017/18.

 

Change of reporting currency to USD

 

Starting with the 2018/19 financial year, BTG will change its reporting currency to USD. This change is reflective of the majority of the Group's revenues and a significant proportion of its operating costs now being denominated in USD.

 

This change to report financial information in USD will take effect from 1 April 2018. BTG will continue to report its current financial year ending 31 March 2018 in GBP.

 

BTG will publish historical financial information, restated to USD, in advance of the transition to assist investors and analysts to prepare for the future change to a USD reporting currency.

 

 

CONDENSED CONSOLIDATED INCOME STATEMENT

for the six months ended 30 September 2017
			Six months ended 30 September 2017 Total			Six months ended 30 September 2016 Total
	Note		£m			£m
Revenue	2		341.3			285.4
Cost of sales			(104.2)			(88.7)
Gross profit	2		237.1			196.7
Selling, general and administrative expenses			(152.2)			(110.4)
Research and development			(46.1)			(37.8)
Other operating income			1.2			1.6
Amortisation of acquired intangible assets			(21.4)			(19.9)
Acquisition and reorganisation costs			-			(1.1)
Operating profit			18.6			29.1
Financial income	3		38.0			0.1
Financial expense	3		(9.4)			(18.1)
Profit before tax			47.2			11.1
Tax credit	4		5.7			1.8
Profit after tax			52.9			12.9
Attributable to non-controlling interests			(0.4)			-
Attributable to owners of the parent			53.3			12.9
Profit after tax			52.9			12.9
Basic earnings per share	5		13.8p			3.4p
Diluted earnings per share	5		13.7p			3.3p

All activities arose from continuing operations.

 

CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME

for the six months ended 30 September 2017
			Six months ended 30 September 2017		Six months ended 30 September 2016
		Note	£m		£m
Profit after tax			52.9		12.9
Other comprehensive (loss) / income
Items that may be reclassified subsequently to profit or loss
Foreign exchange translation differences			(48.3)		61.5
Items that will not be reclassified subsequently to profit or loss
Actuarial loss on defined benefit pension scheme		7	(0.1)		(2.6)
Deferred tax on defined benefit pension scheme asset			-		0.9
Other comprehensive (loss) / income for the period			(48.4)		59.8
Total comprehensive income for the period			4.5		72.7
Attributable to non-controlling interests			(0.4)		-
Attributable to owners of the parent			4.9		72.7
Total comprehensive income for the period			4.5		72.7

 

 

 

CONDENSED CONSOLIDATED STATEMENT OF FINANCIAL POSITION as at 30 September 2017
		30 September 2017	31 March 2017		30 September 2016
	Note	£m	£m		£m
ASSETS
Non-current assets
Goodwill	6	216.0		225.6	220.1
Intangible assets	6	613.9		678.9	679.9
Property, plant and equipment		38.1		40.1	40.8
Deferred tax assets		4.5		5.3	8.6
Employee benefits	7	18.6		17.2	18.2
Other non-current assets		1.6		1.7	1.6
		892.7		968.8	969.2
Current assets
Inventories		53.2		58.4	52.1
Trade and other receivables		128.2		125.7	121.4
Other current assets		4.1		2.7	1.6
Cash and cash equivalents		226.5		155.5	144.0
		412.0		342.3	319.1
Total assets		1,304.7		1,311.1	1,288.3
EQUITY
Share capital		38.6		38.5	38.5
Share premium		437.2		435.4	435.2
Merger reserve		317.8		317.8	317.8
Other reserves		71.5		119.8	89.6
Retained earnings		124.1		68.4	44.9
Total equity		989.2		979.9	926.0
LIABILITIES
Non-current liabilities
Trade and other payables		4.8		8.5	33.7
Deferred tax liabilities		132.8		157.2	168.5
Derivative financial instruments		-		-	1.8
		137.6		165.7	204.0
Current liabilities
Trade and other payables		117.5		152.0	144.5
Provisions	11	56.7		0.5	1.9
Derivative financial instruments		1.1		7.9	8.5
Corporation tax payable		2.6		5.1	3.4
		177.9		165.5	158.3
Total liabilities		315.5		331.2	362.3
Total equity and liabilities		1,304.7		1,311.1	1,288.3

 

 

 

CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS
for the six months ended 30 September 2017
		Six months ended 30 September 2017	Six months ended 30 September 2016
	Note	£m	£m
Profit after tax for the period		52.9	12.9
Tax credit	4	(5.7)	(1.8)
Financial income	3	(38.0)	(0.1)
Financial expense	3	9.4	18.1
Operating profit		18.6	29.1
Adjustments for:
Profit on disposal of property, plant and equipment and  intangible assets		-	(0.9)
Amortisation and impairments of intangible assets		28.9	22.0
Depreciation on property, plant and equipment		4.4	3.7
Share-based payments		3.2	5.0
Pension scheme funding	7	(1.4)	(1.4)
Fair value adjustments		0.1	0.7
Cash flows from operations before movements in working capital		53.8	58.2
Decrease/(increase) in inventories		3.4	(2.2)
Increase in trade and other receivables		(8.3)	(11.1)
(Decrease)/increase in trade and other payables		(15.9)	29.3
Increase in provisions		55.5	0.4
Cash generated from operations		88.5	74.6
Settlement of foreign exchange forward contracts		(2.2)	(6.5)
Taxation paid		(7.5)	(7.3)
Net cash inflow from operating activities		78.8	60.8
Cash flows from investing activities
Purchases of intangible assets		(0.5)	(0.2)
Purchases of property, plant and equipment		(3.1)	(4.9)
Acquisition of businesses, net of cash acquired	8	(1.7)	(36.4)
Net cash outflow from investing activities		(5.3)	(41.5)
Cash flows from financing activities
Repayment of debt acquired with Galil Medical		-	(18.9)
Proceeds from issue of shares		1.9	0.6
Other financing activities		(0.7)	(1.1)
Net cash inflow/(outflow) from financing activities		1.2	(19.4)
Increase / (decrease) in cash and cash equivalents		74.7	(0.1)
Cash and cash equivalents at start of period		155.5	140.4
Effect of exchange rate fluctuations on cash held		(3.7)	3.7
Cash and cash equivalents at end of period		226.5	144.0

 

 

 

CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
for the six months ended 30 September 2017
		Share capital	Share premium	Merger reserve	Other reserves	Retained earnings	Total attributable to owners of the parent	Attributable to non-controlling interests	Total equity
		£m	£m	£m	£m	£m	£m	£m	£m
At 1 April 2017		38.5	435.4	317.8	119.8	68.4	979.9	-	979.9
Profit for the period		-	-	-	-	53.3	53.3	(0.4)	52.9
Other comprehensive loss		-	-	-	(48.3)	(0.1)	(48.4)	-	(48.4)
Total comprehensive (loss)/income for the period		-	-	-	(48.3)	53.2	4.9	(0.4)	4.5
Transactions with owners:
Issue of ordinary shares		0.1	1.8	-	-	-	1.9	-	1.9
Arising on business combinations		-	-	-	-	-	-	0.4	0.4
Movement in shares held by the Employee Share Ownership Trust		-	-	-	-	(0.7)	(0.7)	-	(0.7)
Share-based payments		-	-	-	-	3.2	3.2	-	3.2
At 30 September 2017		38.6	437.2	317.8	71.5	124.1	989.2	-	989.2

 

 

 

		Share capital	Share premium	Merger reserve	Other reserves	Retained earnings	Total equity
		£m	£m	£m	£m	£m	£m
At 1 April 2016		38.3	434.8	317.8	28.1	28.7	847.7
Profit for the period		-	-	-	-	12.9	12.9
Other comprehensive income/(loss)		-	-	-	61.5	(1.7)	59.8
Total comprehensive income for the period		-	-	-	61.5	11.2	72.7
Transactions with owners:
Issue of ordinary shares		0.2	0.4	-	-	-	0.6
Share-based payments		-	-	-	-	5.0	5.0
At 30 September 2016		38.5	435.2	317.8	89.6	44.9	926.0

 

 

 

NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

 

1.   Basis of preparation

 

Statement of compliance

 

These condensed consolidated interim financial statements have been prepared in accordance with IAS 34 Interim Financial Reporting. They do not contain all of the information which International Financial Reporting Standards ("IFRS") would require for a complete set of annual financial statements, and should be read in conjunction with the consolidated financial statements of the Group for the year ended 31 March 2017.

 

These condensed unaudited consolidated interim financial statements were approved by the Board of Directors on
13 November 2017.

 

Comparative financial information

 

The comparative figures for the financial year ended 31 March 2017 do not constitute the Group's statutory accounts for that financial year. Statutory accounts for the year ended 31 March 2017, prepared in accordance with International Financial Reporting Standards as adopted by the EU ("Adopted IFRSs") and as issued by the International Accounting Standards Board, have been reported on by the Group's auditor and delivered to the Registrar of Companies. The report of the auditor was (i) unqualified, (ii) did not include a reference to any matters to which the auditor drew attention by way of emphasis without qualifying their report, and (iii) did not contain a statement under section 498 (2) or (3) of the Companies Act 2006.

 

Accounting policies

 

The accounting policies applied by the Group in these condensed consolidated interim financial statements are the same as those applied by the Group in its consolidated financial statements for the year ended 31 March 2017.

 

No standard and interpretations recently adopted by the EU have a significant impact on the Group.

 

IFRS 15 'Revenue from contracts with customers', was issued by the IASB in May 2014 and will be implemented by the Group from 1 April 2018. The Standard contains a new set of principles on when and how to recognise and measure revenue as well as new requirements related to disclosures. The new standard replaces IAS 18 Revenues and related interpretations. The Group does not anticipate that the new standard will have a material effect on the Group's consolidated financial statements.

 

IFRS 9 'Financial instruments' was issued by the IASB in July 2014, and will be implemented by the Group from 1 April 2018.  The Group is currently assessing the impact of IFRS 9 on the Group's consolidated financial statements.

 

IFRS 16 'Leases' was issued by the IASB in January 2016, and will be implemented by the Group from 1 April 2019.  The Group is currently assessing the impact of IFRS 16 on the Group's consolidated financial statements.

 

IFRIC 23 'Uncertainty over income tax treatments' was issued by the IASB in July 2017 and will be implemented by the Group from 1 April 2019. The Group is currently assessing the impact of IFRIC 23 on the Group's consolidated financial statements.  

 

Going concern and liquidity

 

After making enquiries, the Directors have a reasonable expectation that the Group has adequate resources to continue in operational existence for the next 12 months. Accordingly, they continue to adopt the going concern basis in preparing these Interim Financial Statements.

 

This conclusion has been reached having considered the effect of liquidity risk on the Group's ability to operate effectively. Currently, liquidity risk is not considered a significant business risk to the Group given its level of net cash and cash equivalents and cash flow projections. The Group does not currently require significant levels of debt financing to operate its business. The key liquidity risks faced by the Group are considered to be the failure of banks where funds are deposited and the failure of key licensees, distribution partners, wholesalers or insurers.

 

In addition to the liquidity risk considered above, the Directors have also considered the following factors when reaching the conclusion to continue to adopt the going concern basis:

 

·    A significant proportion of the Group's sales are from products which are life-saving in nature, providing some protection against an uncertain economic outlook;

·    The Group's principal licensees are global industry leaders in their respective fields; and

·    On 7 November 2017, the Group re-financed its multi-currency revolving credit facility ("RCF") which was otherwise due to expire in November 2018. Following the re-financing, BTG has a £150m multi-currency RCF, with an option to increase the RCF by a further £150m. The RCF has a three-year term which expires in November 2020, although the Group has the option to extend the term of the RCF for up to an additional two years. The RCF currently remains undrawn.

 

Seasonality of the business

 

Revenues from the Group's marketed products are dependent on both the timing of shipments of product to the Group's distributors and the underlying demand for the products. CroFab^®, in particular, demonstrates seasonality since the main snakebite season in the US, when the product is in highest demand, runs from March to October.

 

2.   Operating segments

 

Operating segments are reported based on the financial information provided to the Group's chief operating decision-making body, being the Leadership Team. The Group is aligned behind three reportable segments, being Interventional Medicine, Pharmaceuticals and Licensing.

 

In assessing performance and making resource allocation decisions, the Leadership Team reviews contribution by segment. Contribution is defined as being gross profit less directly attributable selling, general and administrative costs (SG&A). The Licensing operating segment includes SG&A relating to the Group's centrally managed support functions and corporate overheads. These reportable segments reflect the management structure and stewardship of the business. No allocation of central overheads is made across the Pharmaceuticals or Interventional Medicine reportable segments. Research and development continues to be managed on a global basis, with investment decisions being made by the Leadership Team as a whole. Research & Development is not managed by reference to the Group's reportable segments, though each programme within the pipeline would ultimately provide revenues for one of the reportable segments if successful.

 

		Six months ended 30 September 2017
	Interventional Medicine		Pharmaceuticals	Licensing	Total
	£m		£m	£m	£m
Revenue		118.8	120.9	101.6	341.3
Cost of Sales1		(35.0)	(14.5)	(54.7)	(104.2)
Gross Profit		83.8	106.4	46.9	237.1
Selling, general and administrative expenses2		(63.2)	(75.9)	(13.1)	(152.2)
Contribution		20.6	30.5	33.8	84.9
Research and development					(46.1)
Other operating income					1.2
Amortisation of acquired intangible assets					(21.4)
Operating profit					18.6
Financial income					38.0
Financial expense					(9.4)
Profit before tax					47.2
Tax credit					5.7
Profit after tax					52.9
Unallocated assets3					1,088.7

 

¹ 2017 cost of sales within the Interventional Medicine segment includes a £0.1m release of a fair value adjustment to PP&E acquired with Galil Medical in June 2016. The release represents incremental depreciation related to acquired PP&E.

² 2017 selling, general and administrative expenses within Pharmaceuticals includes a charge of £53.5m reflecting amounts provided in respect of the litigation with Wellstat and an impairment charge of £5.5m relating to the Vistogard^® intangible asset. 

³ The Group does not allocate assets to operating segments, with the exception of goodwill (see note 6).

 

 

 

	Six months ended 30 September 2016
	Interventional Medicine	Pharmaceuticals	Licensing	Total
	£m	£m	£m	£m
Revenue	98.1	95.1	92.2	285.4
Cost of Sales1	(28.4)	(10.7)	(49.6)	(88.7)
Gross Profit	69.7	84.4	42.6	196.7
Selling, general and administrative expenses2	(53.4)	(13.6)	(43.4)	(110.4)
Contribution	16.3	70.8	(0.8)	86.3
Research and development				(37.8)
Other operating income				1.6
Amortisation of acquired intangible assets				(19.9)
Acquisition and reorganisation costs				(1.1)
Operating profit				29.1
Financial income				0.1
Financial expense				(18.1)
Profit before tax				11.1
Tax credit				1.8
Profit for the period				12.9
Unallocated assets3				1,068.2

 

¹ 2016 cost of sales within the Interventional Medicine segment includes a £0.7m release of a fair value adjustment to inventory and PP&E acquired with Galil Medical in June 2016. The release represents the reversal of a fair value uplift applied to inventory purchased on acquisition which is recognised through the income statement when inventory is sold, and incremental depreciation related to acquired PP&E.

² 2016 selling, general and administrative expenses within Licensing includes a charge of £28.0m relating to the Group's settlement with the US government in relation to the Department of Justice investigation into the historic marketing of LC Bead^®. 

³ The Group does not allocate assets to operating segments, with the exception of goodwill (see note 6).

 

Revenue analysis

 

An analysis of revenue, based on the geographical location of customers and the source of revenue is provided below:

 

Geographical analysis	Six months ended 30 September 2017	Six months ended 30 September 2016
	£m	£m
USA	312.4	258.8
Europe	21.9	19.2
Other regions	7.0	7.4
	341.3	285.4

 

Revenue from major products and services	Six months ended 30 September 2017	Six months ended 30 September 2016
	£m	£m
Product sales	239.7	193.2
Royalties	101.6	92.2
	341.3	285.4

 

Major customers

 

The Group's marketed products are sold both directly and through distribution agreements in the USA, Europe, Asia Pacific and other regions. No individual customer generated income in excess of 10% of Group revenue in either period.

 

Products that utilise the Group's Intellectual Property Rights are sold by licensees. Royalty income is derived from over 40 licences. One licence individually generated royalty income in excess of 10% of Group revenue of £71.0m (H1 16/17: one licence individually generated £65.8m).

 

3.   Financial income and expense

 

		Six months ended 30 September 2017	Six months ended 30 September 2016
	Note	£m	£m
Fair value movements and realised gains on foreign exchange forward contracts		11.4	-
Interest receivable on money market and bank deposits		0.1	0.1
Fair value movements on contingent consideration liabilities	9	26.5	-
Financial income		38.0	0.1
Fair value movements and realised losses on foreign exchange forward contracts		4.8	17.0
Fair value movements on contingent consideration liabilities	9	3.7	0.3
Other financial expense		0.9	0.8
Financial expense		9.4	18.1

 

The contingent consideration liabilities payable in relation to the Galil and PneumRx acquisitions have been re-measured at fair value at 30 September 2017, with gains on re-measurement recorded within Financial income and losses recorded within Financial expense. See Note 9 for further details.

 

4.   Tax

 

	Six months ended 30 September 2017	Six months ended 30 September 2016
	£m	£m
Current tax
Current tax charge	5.0	5.0
Deferred tax
Decrease in net deferred tax liability	(11.5)	(4.9)
Decrease / (increase) in net deferred tax asset	0.8	(1.9)
Total tax credit for the period	(5.7)	(1.8)

 

Tax for each six-month period has been provided on the basis of the anticipated tax charge for the full year. The current tax charge of £5.0m (H1 2016/17: £5.0m) principally relates to UK and US taxes.

 

The deferred tax credit of £10.7m (H1 16/17: £6.8m credit) principally reflects the release of deferred tax liabilities recognised on acquired intangible assets as these assets are amortised or impaired (£6.9m), the initial recognition of deferred tax assets (£2.9m) and other timing differences partly offset by use of recognised tax losses (£0.9m). Previously unrecognised tax losses of £7.0m (gross) are expected to be recognised in the year, due to the expectation that there will be sufficient taxable profits in the future against which these losses can be utilised.

 

 

 

5.   Earnings per share

 

The calculation of basic and diluted earnings per share is determined as follows:

	Six months ended 30 September 2017	Six months ended 30 September 2016
Profit for the period attributable to the parent (£m)	53.3	12.9
Earnings per share (p)
Basic	13.8	3.4
Diluted	13.7	3.3
Number of shares (m)
Weighted average number of shares - basic	385.8	383.8
Effect of share options in issue	2.9	5.7
Weighted average number of shares - diluted	388.7	389.5

 

For the calculation of adjusted basic and diluted earnings per share see page 25 and 26.

 

6.   Goodwill and other intangible assets

 

a)   Goodwill

 

Goodwill at 30 September 2017 is £216.0m (31 March 2017: £225.6m; 30 September 2016: £220.1m). The movement in the current period principally relates to foreign exchange movements.

 

The carrying value of goodwill has been allocated to Interventional Medicine £179.5m (31 March 2017: £189.1m; 30 September 2016: £183.6m), to Pharmaceuticals £16.4m (31 March 2017: £16.4m; 30 September 2016: £16.4m) and to Licensing £20.1m (31 March 2017: £20.1m; 30 September 2016: £20.1m).

 

b)   Other intangible assets

 

The net book value of other intangible assets at 30 September 2017 is £613.9m (31 March 2017: £678.9m; 30 September 2016: £679.9m). The decrease in the carrying value of intangible assets between 31 March 2017 and 30 September 2017 relates to foreign exchange retranslation of those assets denominated in foreign currencies, amortisation of finite-lived intangible assets and impairment charges.

 

An impairment charge of £5.5m was recorded within SG&A in the period to 30 September 2017 (H1 16/17: £nil). As a result of the court ruling in the litigation with Wellstat, the Group is required to return the US distribution rights for Vistogard^® to Wellstat after a transition period. Accordingly the Vistogard^® intangible asset was determined to be fully impaired.

 

7.   Defined benefit pension fund

 

The Group has recognised a net defined benefit asset of £18.6m on the Group's balance sheet in accordance with IAS19 - Employee benefits in relation to the BTG Pension Fund (31 March 2017: asset of £17.2m; 30 September 2016: asset of £18.2m). The £1.4m increase since 31 March 2017 relates principally to an increase in the discount rate used to value the obligation and the impact of deficit repair payments, partially offset by lower than expected investment returns. Actuarial gains/losses are recognised in the condensed consolidated statement of comprehensive income.

 

In November 2016, the Group finalised the triennial actuarial valuation of the BTG Pension Fund as at 31 March 2016. The valuation showed a deficit of £4.6m and the Group committed to deficit repair payments of £5.2m in aggregate over the period to 31 October 2018. In the period to 30 September 2017, deficit repair payments of £1.2m (H1 16/17: £1.2m) have been made.

 

8.   Business Combinations

 

Galil Medical acquisition

 

On 15 June 2016 BTG completed the acquisition of 100% of Galil Medical. The fair value of the consideration paid totalled £39.1m, representing up-front cash consideration of £37.5m and the fair value of contingent consideration of £1.6m.

 

The fair value of acquired assets and assumed liabilities was finalised in the period to 30 September 2017. No adjustments have been made to the preliminary fair values presented in the Annual Report and Accounts for the year ended 31 March 2017.

 

OncoVerse LLC ('OncoVerse') acquisition

 

On 20 April 2017, BTG acquired a 55% equity stake in OncoVerse, a US company, for cash consideration of £1.9m ($2.5m). OncoVerse is developing a digital health platform designed to allow cancer patients' care teams to collaborate and allow clinicians across all disciplines to work together to determine the most effective treatment plan for their patients.

 

OncoVerse's results of operations have been consolidated from 20 April 2017, with that portion attributable to the 45% of OncoVerse equity not owned by BTG recorded within "Non-controlling interests". The impact of OncoVerse on the Group's income statement is immaterial. The fair values of assets acquired and liabilities assumed have also been determined as of 20 April 2017. The final determination of these fair values will be completed as soon as possible but no later than one year from the date of acquisition.

 

Consolidation of Vetex Medical Limited ('Vetex')

 

On 17 July 2017 BTG provided Vetex, a development-stage medical device company based in Ireland, with £2.0m ($2.7m) cash in exchange for a convertible loan note and a call option over 100% of Vetex's share capital.

 

As a result of these transactions, it is deemed that BTG has the current ability (irrespective of intent) to exercise power over Vetex's primary value generating activities. Accordingly, the results of Vetex have been consolidated from 17 July 2017, with that portion attributable to the 100% of Vetex equity not owned by BTG recorded within "Non-controlling interests". The impact of Vetex on the Group's income statement is immaterial. The fair values of assets acquired and liabilities assumed have also been determined as of 17 July 2017. The final determination of these fair values will be completed as soon as possible but no later than one year from the date of acquisition.

 

9.   Financial instruments and fair value measurements

 

Recurring fair value measurements

Financial instruments are classified into Level 1, Level 2 and Level 3 financial instruments. The different levels are defined as follows:

 

Level 1 - quoted prices in active markets for identical assets and liabilities

Level 2 - observable inputs other than quoted prices in active markets for identical assets and liabilities

Level 3 - unobservable inputs

 

The Group's Level 1 and Level 2 financial instruments comprise cash and deposits, foreign exchange forward contracts, and various items such as trade receivables and payables which arise directly from operations.

 

The carrying amount of the Group's Level 1 and Level 2 financial instruments is a reasonable approximation of their fair value. There have been no transfers between the levels of financial instruments in the period.

 

The Group's Level 3 financial instruments predominantly represent:

·    the contingent consideration payable on achievement of revenue targets and product approval relating to PneumRx following the acquisition of PneumRx, Inc. in January 2015; and

·    the contingent consideration payable on achievement of revenue targets and product approval relating to Galil Medical following the acquisition of Galil Medical in June 2016.

 

The movement in the Level 3 financial liabilities is shown below:

	2017	2016
	£m	£m
At 1 April	(32.1)	(27.2)
Acquisitions	-	(1.6)
Change in fair value	22.8	(0.3)
Foreign exchange retranslation	1.8	(2.7)
At 30 September	(7.5)	(31.8)

 

In the period to 30 September 2017, the Group recognised a fair value credit of £26.5m relating to the PneumRx^® US regulatory approval milestone. This $60m regulatory milestone would be payable if the PneumRx^® Coils product is approved by the FDA no later than 31 December 2017. The Group has recognised a credit of £26.5m, fully releasing the related contingent consideration liability, as the Group now considers that any FDA approval will not be received before 31 December 2017.

 

In addition the Group recognised a fair value charge of £3.7m within 'Financial expense' related to contingent consideration payable pursuant to the Galil acquisition, reflecting increased confidence in achieving certain regulatory milestones within the relevant milestone earn-out periods.

 

10. Related parties

 

Giles Kerr, a non-executive director of BTG plc, is also the Director of Finance for Oxford University and a director of Oxford University Innovation Limited, a wholly-owned subsidiary of Oxford University. Wholly-owned subsidiaries of BTG plc entered into revenue sharing agreements with these organisations prior to Giles Kerr joining the BTG Board. The BTG Group has licensed the intellectual property covered by these agreements to third party companies that are developing and/or selling the licensed products. Under these licence agreements, BTG is entitled to receive milestone payments and/or a royalty on sales of the products made by the third party licensees. Payments made by BTG to Oxford University and Oxford University Innovation Limited under the relevant licence agreements were £10,000 in the period ended 30 September 2017 (H1 16/17: £9,000) and there were no amounts outstanding and payable at 30 September 2017 (H1 16/17: £nil).

 

11. Provisions

 

On 19 September 2017 a Memorandum Opinion was issued by the Court of Chancery of Delaware ruling against BTG in its previously announced litigation with Wellstat Therapeutics Corporation concerning the commercialisation of Vistogard^®. The Court found that BTG has breached the distribution agreement and that Wellstat is entitled to damages plus interest and costs. On 2 November 2017 the Court issued a Final Order and Judgment consistent with the initial September ruling, and requiring that BTG return the US distribution rights for Vistogard^® to Wellstat after a transition period. In the period to 30 September 2017, BTG has recorded a provision for £53.5m expensed within SG&A, with the amount of this provision based on the damages awarded and pre- and post-judgment interest calculated pursuant to the Final Order.

 

BTG is currently considering its options in relation to this Final Order and Judgement, which include an appeal.

 

12. Subsequent events

 

On 5 October 2017 BTG announced the acquisition of 100% of the share capital of Roxwood Medical, Inc., an innovative provider of advanced cardiovascular specialty catheters used in the treatment of patients with severe coronary and peripheral artery disease. The acquisition continues to build BTG's strength in the interventional vascular space, further expanding BTG's portfolio of differentiated minimally invasive vascular technologies.

 

BTG will pay up to US$80m in cash consideration to acquire Roxwood, comprising US$65m paid on closing (subject to customary closing adjustments) and up to an additional US$15m contingent upon achievement of future commercial milestones.

 

The initial accounting for this acquisition, including the fair valuation of contingent consideration payable and assets acquired, is in progress. Further disclosures will be provided in BTG's 2018 Annual Report and Accounts.

 

13. Principal risks and uncertainties

 

We have considered the principal risks and uncertainties faced by the Group for the remaining six months of the year and do not consider them to have changed from those set out on pages 68 to 70 of the BTG plc 2017 Annual Report and Accounts, available from the Group's website at www.btgplc.com. These include but are not limited to: market access; securing adequate reimbursement for BTG's products; obtaining/ maintaining product regulatory approvals; IP/Legal challenges; competition; healthcare law compliance; and supply chain/continuity of supply.

 

 

 

Responsibility statement of the directors in respect of the interim financial report

The directors confirm that this set of interim condensed financial statements has been prepared in accordance with IAS 34 'Interim Financial Reporting' as adopted by the European Union and that the interim management report includes a fair review of the information required by DRT 4.2.7R and DRT 4.2.8R, namely:

 

·    An indication of important events that have occurred during the period and their impact on the condensed statements; and a description of the principal risks and uncertainties for the remaining six months of the year; and

·    Related party transactions that have taken place in the first six months of the current fiscal year and that have materially affected the financial position or performance of the entity during the period; and any changes in related party transactions described in the last annual report that could do so.

 

The directors of BTG plc were listed in the BTG plc Annual Report for the year ended 31 March 2017. There have been no changes in the period. 

 

The Board

 

The Board of Directors that served during the six-month period to 30 September 2017 and their respective responsibilities can be found on the company website, www.btgplc.com.

 

By order of the Board

 

Dr Louise Makin	Chief Executive Officer
Rolf Soderstrom	Chief Financial Officer

 

13 November 2017

 

 

 

Independent Review Report to BTG plc

 

Conclusion 

 

We have been engaged by the company to review the condensed set of financial statements in the half-yearly financial report for the six months ended 30 September 2017 which comprises the Group's condensed consolidated income statement, condensed consolidated statement of comprehensive income, condensed consolidated statement of financial position, condensed consolidated statement of cash flows and the condensed consolidated statement of changes in equity and the related explanatory notes.

 

Based on our review, nothing has come to our attention that causes us to believe that the condensed set of financial statements in the half-yearly financial report for the six months ended 30 September 2017 is not prepared, in all material respects, in accordance with IAS 34 Interim Financial Reporting as adopted by the EU and the Disclosure Guidance and Transparency Rules ("the DTR") of the UK's Financial Conduct Authority ("the UK FCA").

 

Scope of review 

 

We conducted our review in accordance with International Standard on Review Engagements (UK and Ireland) 2410 Review of Interim Financial Information Performed by the Independent Auditor of the Entity issued by the Auditing Practices Board for use in the UK.  A review of interim financial information consists of making enquiries, primarily of persons responsible for financial and accounting matters, and applying analytical and other review procedures.  We read the other information contained in the half-yearly financial report and consider whether it contains any apparent misstatements or material inconsistencies with the information in the condensed set of financial statements. 

 

A review is substantially less in scope than an audit conducted in accordance with International Standards on Auditing (UK) and consequently does not enable us to obtain assurance that we would become aware of all significant matters that might be identified in an audit.  Accordingly, we do not express an audit opinion. 

 

Directors' responsibilities 

 

The half-yearly financial report is the responsibility of, and has been approved by, the directors.  The directors are responsible for preparing the half-yearly financial report in accordance with the DTR of the UK FCA. 

 

As disclosed in note 1, the annual financial statements of the Group are prepared in accordance with International Financial Reporting Standards as adopted by the EU.  The directors are responsible for preparing the condensed set of financial statements included in the half-yearly financial report in accordance with IAS 34 as adopted by the EU.  

 

Our responsibility 

 

Our responsibility is to express to the company a conclusion on the condensed set of financial statements in the half-yearly financial report based on our review. 

 

The purpose of our review work and to whom we owe our responsibilities

This report is made solely to the company in accordance with the terms of our engagement to assist the company in meeting the requirements of the DTR of the UK FCA.  Our review has been undertaken so that we might state to the company those matters we are required to state to it in this report and for no other purpose.  To the fullest extent permitted by law, we do not accept or assume responsibility to anyone other than the company for our review work, for this report, or for the conclusions we have reached. 

 

 

Richard Broadbelt

For and on behalf of KPMG LLP

Chartered Accountants

15 Canada Square

London E14 5GL

 

13 November 2017

 

 

 

Shareholder information

 

Financial calendar

Announcement of annual results for year ending 31 March 2018

May 2018

 

Link share dealing services

 

A quick and easy share dealing service is available from Link Asset Services, to either buy or sell more shares. An online and telephone dealing facility is available providing shareholders with an easy-to-access and simple-to-use service. For further information on this service, or to buy and sell shares, please contact: www.linksharedeal.com (online dealing) or +44 (0) 371 664 0445 (telephone dealing) - calls are charged at the standard geographic rate and will vary by provider, lines are open 8am - 4.30pm Monday - Friday. Full terms, conditions and risks apply and are available on request or by visiting www.linksharedeal.com.

 

This is not a recommendation to buy or sell shares. The price of shares can go down as well as up, and you are not guaranteed to get back the amount that you originally invested.

 

Shareholder change of address

 

The Company offers the facility, in conjunction with Link Asset Services, our Registrars, to conduct a number of routine matters via the web including the ability to notify any change of address. If you are a shareholder and are either unable or would prefer not to use this facility, please do not send the notification to the Company's registered office. Please write direct to Link Asset Services, at their address shown below, where the register is held.

 

Relating to beneficial owners of shares with 'information rights'

 

Please note that beneficial owners of shares who have been nominated by the registered holder of those shares to receive information rights under section 146 of the Companies Act 2006 are required to direct all communications to the registered holder of their shares rather than to the Company's registrar, Link Asset Services, or to the Company directly.

Addresses for correspondence

Registered office and head office	Registrars
BTG plc 5 Fleet Place London EC4M 7RD Tel: +44 (0)20 7575 0000 Fax: +44 (0)20 7575 0010 Email: info@btgplc.com   Website: www.btgplc.com   Registered number 2670500	Link Asset Services The Registry 34 Beckenham Road Beckenham Kent BR2 4TU   Tel (callers from the UK)  0871 664 0300 (please note that calls cost 10p per minute, plus network extras, lines are open 9.00am - 5.30pm Monday - Friday) Tel (callers outside UK)  +44 208 639 3399

 

Cautionary statement regarding forward-looking statements

 

This document contains certain projections and other forward-looking statements with respect to the financial condition, results of operations, businesses and prospects of BTG plc ("BTG"). These statements are based on current expectations and involve risk and uncertainty because they relate to events and depend upon circumstances that may or may not occur in the future. There are a number of factors which could cause actual results or developments to differ materially from those expressed or implied by these forward-looking statements. Any of the assumptions underlying these forward-looking statements could prove inaccurate or incorrect and therefore any results contemplated in the forward-looking statements may not actually be achieved. Nothing contained in this document should be construed as a profit forecast or profit estimate. Investors or other recipients are cautioned not to place undue reliance on any forward-looking statements contained herein. BTG undertakes no obligation to update or revise (publicly or otherwise) any forward-looking statement, whether as a result of new information, future events or other circumstances.

 

BTG and the BTG roundel logo are registered trademarks of BTG International Ltd. CroFab and DigiFab are registered trademarks of BTG International Inc. LC Bead is a registered trademark of Biocompatibles UK Ltd. EKOS is a registered trademark of EKOS Corporation. GALIL is a trademark of Galil Medical Ltd. Lemtrada is a trademark of Genzyme Corporation. PneumRx is a registered trademark of PneumRx, Inc. TheraSphere is a registered trademark of Theragenics Corporation used under license by Biocompatibles UK Ltd. Varithena is a registered trademark of Provensis Ltd. Vistogard is a registered trademark of Wellstat Therapeutics Corporation. Voraxaze is a registered trademark of Protherics Medicines Development Ltd. Zytiga is a trademark of Johnson & Johnson. Biocompatibles UK Ltd, EKOS Corporation, Galil Medical Ltd, PneumRx, Inc., Protherics Medicines Development Ltd, and Provensis Ltd are all BTG International group companies. 

 

 

 

Appendices -reconciliation of IFRS to adjusted financial information

 

Information on adjusted financial information

 

This press release includes financial information prepared in accordance with International Financial Reporting Standards and the Group's accounting policies, as well as financial information presented on an adjusted basis.

 

Financial information on an adjusted basis excludes certain cash and non-cash items which management believe are not reflective of the underlying financial performance of the business and is consistent with how management reviews the business for the purpose of making operating decisions.

 

Metrics presented on an adjusted basis includes Constant Exchange Rate (CER) growth, Adjusted Gross Profit, Adjusted SG&A, Contribution, Adjusted Operating Profit, Adjusted Net Financial Income / Expense, Adjusted Effective Tax Rate, Adjusted Basic EPS and Free cash flow. A reconciliation between IFRS and adjusted financial information is included on pages 24 to 26 of this release.

 

These metrics are further discussed below;

·    CER growth: CER growth is calculated by restating H1 2017/18 performance using H1 2016/17 exchange rates for the relevant period. CER growth allows management to focus on underlying performance without the impact of foreign exchange, which it cannot control.

·    Adjusted Operating Profit: Adjusted operating profit reflects the IFRS operating profit of the Group excluding the impact of certain adjustments, which have been separately outlined below. Adjusted operating profit allows management to assess operational performance without the impact of certain items which are not reflective of underlying financial performance. 

·    Adjusted Basic EPS: Adjusted Basic EPS reflects Basic EPS excluding the after tax impact of certain adjustments, which have been outlined below. Adjusted Basic EPS allows management to assess EPS without the impact of certain items which are not reflective of underlying financial performance.

·    Free Cash Flow: Reflects the cash generated from operating activities after recurring capital expenditure, being a measure of cash flow available for discretionary investing or financing activities. The reconciliation of free cash flow to net cash flows from operating activities is show on page 26.

·    Contribution: Contribution is defined as gross profit less SG&A, which broadly reflects the cash generated by the Group's reportable segments before investment in R&D or other investing or financing activities. Management use this metric to assess performance for each of its reportable segments and reviews the metric both including and excluding the impact of certain adjustments outlined below.

 

Adjusted gross profit, Adjusted SG&A, Adjusted Finance Income / Expense and Adjusted effective tax rate are stated after excluding the effect of those items outlined below.

 

Management apply a consistent policy in determining its adjusted financial measures. In determining this policy, outlined below, management assess the nature and materiality of individual or groups of items, and have deemed it appropriate to adjust for those items including their tax effect, which (i) occur outside the normal course of business and (ii) relate to corporate acquisitions or product in-licensing. These adjustments allow better comparability with historical performance and identify year on year trends in the underlying performance of the business.

 

Items excluded from adjusted financial measures in H1 2016/17, H1 2017/18 and from our guidance for the full year 2017/18 are:

 

(a)  Acquisition related adjustments

·    The release of the fair value uplift of acquired inventory or PP&E

·    Amortisation of acquired intangible assets and impairment charges relating to acquired or in-licensed intangible assets or goodwill

·    Fair value adjustments to contingent consideration liabilities

·    Transaction costs incurred in relation to corporate acquisitions

·    Reorganisation costs, including acquisition related redundancy programmes, property costs, and asset impairments.

 

(b)  Net costs relating to the settlement of litigation, disputes and government investigations.

 

Reconciliation between IFRS and Adjusted financial information - Consolidated Income Statement

 

For the period ended 30 September 2017

			IFRS Total				Release of the fair value uplift on acquired PPE1	Amortisation of acquired intangible assets and impairments of acquired or in-licensed intangible assets2		Fair value adjustments to contingent consideration liabilities3		Litigation and other4	Adjusted Total
			£m				£m	£m		£m		£m	£m
Revenue			341.3				-	-		-		-	341.3
Cost of sales			(104.2)				0.1	-		-		-	(104.1)
Gross profit			237.1				0.1	-		-		-	237.2
Selling, general and administrative expenses			(152.2)				-	5.5		-		53.5	(93.2)
Research and development			(46.1)				-	-		-		-	(46.1)
Other operating income			1.2				-	-		-		-	1.2
Amortisation of acquired intangible assets			(21.4)				-	21.4		-		-	-
Operating profit			18.6				0.1	26.9		-		53.5	99.1
Financial income			38.0				-	-		(26.5)		-	11.5
Financial expense			(9.4)				-	-		3.7		-	(5.7)
Profit before tax			47.2				0.1	26.9		(22.8)		53.5	104.9
Tax credit/(charge)			5.7				-	(9.0)		-		(20.8)	(24.1)
Profit after tax			52.9				0.1	17.9		(22.8)		32.7	80.8
Attributable to non-controlling interests			(0.4)				-	-		-		-	(0.4)
Attributable to owners of the parent			53.3				0.1	17.9		(22.8)		32.7	81.2
Profit after tax			52.9				0.1	17.9		(22.8)		32.7	80.8
Weighted average number of shares - basic			385.8										385.8
Weighted average number of shares - diluted			388.7										388.7
Basic earnings per share			13.8p			-		4.6p		(5.9p)		8.5p	21.0p
Diluted earnings per share			13.7p			-		4.6p		(5.9p)		8.5p	20.9p

1.     The release of the fair value uplift relating to PP&E acquired with Galil Medical in June 2016 of £0.1m.

2.     Amortisation charges relating to intangible assets acquired through corporate acquisitions of £21.4m and impairment charges relating the Vistogard^® intangible asset of £5.5m.

3.     Fair value adjustments to contingent consideration liabilities comprise a credit of £26.5m relating to the PneumRx acquisition and a charge of £3.7m relating to the Galil Medical acquisition.

4.     Litigation costs reflect amounts provided based on the Final Order issued by the Court of Chancery of Delaware ruling against BTG in respect of the previously announced litigation with Wellstat Therapeutics Corporation concerning the commercialisation of Vistogard^®. The Court has found that BTG has breached the distribution agreement and that Wellstat is entitled to damages of $55.8m plus interest and costs. BTG is currently assessing its options, which include an appeal.

 

 

 

For the period ended 30 September 2016

		IFRS Total				Release of the fair value uplift on acquired inventory and PPE1	Amortisation of acquired intangible assets2	Acquisition costs3	Fair value adjustments to contingent consideration liabilities4	Litigation and other5	Adjusted Total
		£m				£m	£m	£m	£m	£m	£m
Revenue		285.4				-	-	-	-	-	285.4
Cost of sales		(88.7)				0.7	-	-	-	-	(88.0)
Gross profit		196.7				0.7	-	-	-	-	197.4
Selling, general and administrative expenses		(110.4)				-	-	-	-	28.0	(82.4)
Research and development		(37.8)				-	-	-	-	-	(37.8)
Other operating income		1.6				-	-	-	-	-	1.6
Amortisation of acquired intangible assets		(19.9)				-	19.9	-	-	-	-
Acquisition and reorganisation costs		(1.1)				-	-	1.1	-	-	-
Operating profit		29.1				0.7	19.9	1.1	-	28.0	78.8
Financial income		0.1				-	-	-	-	-	0.1
Financial expense		(18.1)				-	-	-	0.3	-	(17.8)
Profit before tax		11.1				0.7	19.9	1.1	0.3	28.0	61.1
Tax credit/(charge)		1.8				(0.3)	(6.4)	-	-	(2.8)	(7.7)
Profit after tax		12.9				0.4	13.5	1.1	0.3	25.2	53.4
Weighted average number of shares - basic		383.8									383.8
Weighted average number of shares - diluted		389.5									389.5
Basic earnings per share		3.4p			0.1p		3.5p	0.2p	0.1p	6.6p	13.9p
Diluted earnings per share		3.3p			0.1p		3.5p	0.2p	0.1p	6.5p	13.7p

1.     The release of the fair value uplift relating to inventory and PP&E acquired with Galil Medical in June 2016 of £0.7m.

2.     Amortisation charges relating to intangible assets acquired through corporate acquisitions of £19.9m.

3.     Acquisition costs are directly attributable costs related to the acquisition of Galil Medical in June 2016, including costs incurred with professional advisers in relation to the corporate acquisition of £1.1m.

4.     Fair value adjustments to contingent consideration includes the change in fair value of contingent consideration liabilities relating to the PneumRx acquisition of £0.3m.

5.     Settlement with the US government in relation to the Department of Justice's investigation of the historic marketing of LC Bead^® of £28.0m.

 

 

 

Reconciliation between IFRS and Adjusted financial information - Free Cash Flow

 

For the period ended 30 September 2017

Net cash inflow from operating activities	Purchase of intangible assets	Purchase of property, plant and equipment	Free cash Flow
£m	£m	£m	£m
78.8	(0.5)	(3.1)	75.2

 

 

 

For the period ended 30 September 2016

Net cash inflow from operating activities	Purchase of intangible assets	Purchase of property, plant and equipment	Free cash Flow
£m	£m	£m	£m
60.8	(0.2)	(4.9)	55.7